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The opportunity
The Regulatory Affairs Associate is a project manager, (PM) responsible for the RA lifecycle management on Medis dossiers for Teva’s 3rd party client business (Medis), ensuring  information flow and provision of supportive documents reaches the clients
The PM is responsible for liaison with Teva’s 3rd party client business (Medis) supply chain, Teva site RA and other  relevant functions

How you’ll spend your day
Lifecycle management on specific products for Europe and international market
Responsible at all times that regulatory modules under Product Manager responsibility are up to date, in accordance with agreed procedure as applicable
Inform, prepare and submit variations either directly to authorities or to Teva’s 3rd party client business (Medis)
Follow up on variation submissions, timelines and approvals, in accordance with agreed procedure as applicable
Compile answers to any deficiency questions from authorities or clients
Ensure outcomes of variations are communicated in timely manner and databases/lists are up to date at all times, in accordance with agreed procedure  as applicable
Regular status updates to management
Goal setting and follow up together with his/her supervisor
Professional communications with both internal and external stakeholders
Work on other specialized projects as defined by managers of RA